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510(k) Data Aggregation
(372 days)
LUOFUCON Silver Wound Gel, LUOFUCON Silver Antimicrobial Wound Gel
Prescription: LUOFUCON® Silver Wound Gel is under the medical supervision of a healthcare professional for the management of 1st and 2nd degree burns, wounds such as stasis ulcers, pressure ulcers, lacerations, abrasions, skin tears, surgical incision sites, device insertion site wounds, graft sites, and donor sites.
OTC: LUOFUCON® Silver Antimicrobial Wound Gel is indicated for the topical management of minor cuts, minor lacerations and minor burns.
LUOFUCON® Silver Wound Gel /LUOFUCON® Silver Antimicrobial Wound Gel is a sterile, water-based amorphous gel composed of hydrophilic polymer and silver compound. The gel helps to maintain a moist wound environment. The silver compound acts as a preservative to inhibit the growth of microorganisms in the gel during shelf storage.
LUOFUCON® Silver Wound Gel /LUOFUCON® Silver Antimicrobial Wound Gel is supplied in a tube (collapsible, polypropylene tube, sealed on one end and fitted with a screw cap on the other end).
The provided document is a 510(k) summary for the LUOFUCON® Silver Wound Gel / LUOFUCON® Silver Antimicrobial Wound Gel. It describes the device, its intended use, and compares it to predicate devices to demonstrate substantial equivalence.
Based on the content, here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a "table of acceptance criteria" with numerical targets for clinical performance metrics (like sensitivity, specificity, accuracy) that would be common for AI/diagnostic devices. Instead, it focuses on demonstrating substantial equivalence to a predicate device by comparing various physical, chemical, and biological properties, as well as general performance attributes relevant to wound care gels.
The table below summarizes the comparative data presented, which implicitly serves as "acceptance criteria" by showing the subject device is comparable to the predicate/reference devices for key properties and performance aspects.
| Item | Predicate Device (K083103) | Reference Device (K140483) | Subject Device (K211123) | Interpretation (Acceptance/Performance) |
|---|---|---|---|---|
| Device Name | AcryDerm Antimicrobial Silver Gel Wound Dressing Model #B / OTC: AcryDerm Wound Gel Model #B | ASAP OTC Wound Dressing Gel | LUOFUCON® Silver Wound Gel / LUOFUCON® Silver Antimicrobial Wound Gel | Subject device name aligns with product type. |
| Classification Regulation | Unclassified | Unclassified | Unclassified | Acceptance: Matches predicate and reference. |
| Product Code | FRO | FRO | FRO | Acceptance: Matches predicate and reference. |
| Indications for Use (Rx) | Management of 1st and 2nd degree burns, wounds such as stasis ulcers, pressure ulcers, diabetic ulcers, lacerations, abrasions, skin tears, surgical incision sites, device insertion site wounds, graft sites, and donor sites. | N/A | Management of 1st and 2nd degree burns, wounds such as stasis ulcers, pressure ulcers, diabetic ulcers, lacerations, abrasions, skin tears, surgical incision sites, device insertion site wounds, graft sites, and donor sites. | Acceptance: Substantially equivalent to predicate Rx indications. |
| Indications for Use (OTC) | Management of minor abrasions, cuts, lacerations, and scalds. | Topical management of minor cuts, lacerations, abrasions, 1st and 2nd degree burns, and skin irritations. | Topical management of minor abrasions, minor cuts, minor lacerations and minor burns. | Acceptance: Similar to both predicate and reference OTC indications, covering common minor wound types. Minor burns are explicitly included, aligning with the reference device, while the predicate mentioned "scalds." This is considered substantially equivalent. |
| Composition | Hydrophilic polymers and silver salt | Carbopol ETD 2020, triethanolamine, proprietary silver hydrosol suspension | Purified water, Carbopol, glycerol, polyethylene oxide, polyvinyl alcohol, silver compound | Acceptance: While ingredients differ, the overall functional components (hydrophilic polymer, silver compound) are present, supporting a "substantially equivalent" determination based on performance and safety rather than identical formulation. |
| Mechanism | Hydrophilic polymer for maintaining high moisture content, ionic silver for reducing microorganism colonization within the dressing during shelf storage. | Hydrophilic polymer for maintaining high moisture content, silver for reducing microorganism colonization within the dressing during shelf storage. | Hydrophilic polymer for maintaining high moisture content, ionic silver for reducing microorganism colonization within the dressing during shelf storage. | Acceptance: Matches predicate and reference mechanism of action. |
| Antimicrobial Agent | Silver compound | Element silver | Silver compound | Acceptance: All use silver in some form as the antimicrobial agent. |
| Appearance | Slightly cloudy | Clear to golden yellow translucent gel | Colorless to light yellow, transparent to slightly cloudy | Performance: Visually similar, within the range of established devices. |
| pH Value | N/A | 6.5-8.0 | 5.0-7.5 | Performance: Within a physiologically appropriate range for topical applications, comparable to the reference device's range. Implicit acceptance is that it's within a safe and effective range. |
| Silver Content | N/A | 24 ppm | 0.007%-0.012% w/w (which is approximately 70-120 ppm if density is 1g/mL) | Performance: This is a key difference in concentration from the reference device, but the "substantial equivalence" is based on overall performance (e.g., antimicrobial effectiveness, biocompatibility, and non-inhibition of wound healing) rather than exact silver concentration matching. |
| Moisture Donation | N/A | Greater than 5% | ≥10% | Performance: Subject device meets or exceeds the reference device's performance for moisture donation. Implicit acceptance is that higher or comparable donation is favorable. |
| Moisture Absorption | N/A | Greater than 5% | preservative assurance testing | USP |
| Sterilized | N/A | Not provided sterile | Sterile | Acceptance: Provides sterility, which is an advantage over the reference device and aligns with the general expectations for wound care products for significant wounds (Rx). |
The document states: "Performance tests were conducted to demonstrate that the subject device is as effective as its predicate device." The "acceptance criteria" for these performance tests are implicitly met if the test results demonstrate comparable performance attributes to the predicate/reference devices, supporting the claim of substantial equivalence.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not detail specific sample sizes for the performance tests listed (Appearance, Fluid Affinity, Loss on Drying, pH Value, Preservative Effectiveness). These are typically bench tests or in vitro studies, not requiring human patient test sets.
For the Animal Study (Porcine Wound Healing Study):
- Sample Size: Not explicitly stated.
- Data Provenance: Not explicitly stated (e.g., country or retrospective/prospective). This was an animal study, not human clinical data.
For Clinical Studies:
- Sample Size: "No clinical study was conducted."
- Data Provenance: Not applicable, as no human clinical data was used for direct performance evaluation of this device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not applicable to this submission. The device is a wound care gel, not an AI or diagnostic medical device that requires expert adjudication for a test set. The efficacy (or non-inhibition of wound healing) was assessed in an animal model and through comparative performance testing.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable. As mentioned above, this is not an AI/diagnostic device that relies on expert adjudication for ground truth.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable. An MRMC study is relevant for AI/diagnostic imaging devices. This submission concerns a wound care gel.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable. This question refers to AI algorithm performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the various performance tests (Appearance, Fluid Affinity, Loss on Drying, pH Value, Preservative Effectiveness):
- Ground Truth: These properties are determined through standardized laboratory testing methods (e.g., EN 13726-1, USP , USP , USP ). The "ground truth" is the quantitative or qualitative result obtained from these validated methods.
For the Biocompatibility Testing:
- Ground Truth: Compliance with ISO 10993 standards. The "ground truth" is the biological response (or lack thereof) observed in standardized in vitro and in vivo biocompatibility tests, interpreted by toxicologists or biologists.
For the Animal Study (Porcine Wound Healing Study):
- Ground Truth: Histological and macroscopic assessment of wound healing, and observation for adverse biological reactions. This ground truth is established by veterinary pathologists or researchers.
8. The sample size for the training set
This information is not applicable. This device is not an AI algorithm and therefore does not have a "training set."
9. How the ground truth for the training set was established
This information is not applicable. As there is no training set for an AI algorithm, there is no ground truth established for it.
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(25 days)
SILVER ANTIMICROBIAL WOUND GEL
Silver Antimicrobial Wound Gel is indicated under the medical supervision of a healthcare professional for the management of dry to moderate exuding partial and full thickness wounds such as:
- Pressure ulcers
- Leg ulcers
- Diabetic ulcers
- Graft and donor sites
- Post-operative surgical wounds
- Trauma wounds (dermal lesions, trauma injuries or incisions)
- 1st and 2nd degree burns
- Abrasions and lacerations
Silver Antimicrobial Wound Gel is an opaque, amorphous hydrogel containing a high (>80%) water content and hydrophilic polymer chains. This formulation increases the moisture within the wound through water donation which makes the gel effective in assisting the debridement and desloughing process in dry necrotic wounds, whilst maintaining a moist wound environment for optimal wound healing. Silver Antimicrobial Wound Gel contains an antimicrobial silver compound (silver carbonate) that is an effective barrier to bacterial penetration by inhibiting the growth of broad spectrum of microorganisms which come into contact with the gel. Silver Antimicrobial Wound Gel is available in various sizes, and is supplied in aluminium tubes fitted with screw caps. The tubes will be packed in a cardboard dispenser box, with a product insert.
The provided text is a 510(k) summary for a medical device modification, specifically for a Silver Antimicrobial Wound Gel. It describes the device, its intended use, and the testing conducted to demonstrate its safety and effectiveness. However, it does not include specific acceptance criteria with quantifiable metrics (e.g., "device must achieve X% sensitivity or Y% specificity"). Instead, it focuses on demonstrating performance through qualitative statements and comparisons.
Therefore, for the requested table of acceptance criteria and device performance, I can only extract what is stated. For other sections, the information is largely absent based on a typical AI/software device study description.
Here's the analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of this submission (a device modification for a wound care product, not an AI software), the "acceptance criteria" are not presented as numerical thresholds for performance metrics like sensitivity or specificity. Instead, the acceptance is based on demonstrating antimicrobial barrier activity and acceptable wound healing performance compared to a predicate device and standard care.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| In-vitro Antimicrobial Barrier Activity | Effective against: Staphylococcus aureus (including MRSA), Staphylococcus epidermidis (including MRSE), Streptococcus pyogenes, Pseudomonas aeruginosa, Escherichia coli, Candida albicans, and Aspergillus brasiliensis (formerly Aspergillus niger) when they come into contact with the gel. Demonstrated by a seven-day log reduction evaluation test and preservative efficacy test (USP 33 and European Pharmacopoeia Edition 6.6 section 5.1.3). The clinical implications of the in-vitro findings are unknown. |
| Biocompatibility | Compliant with the requirements of BS EN ISO 10993-1 (Biological Evaluation of Medical Devices). |
| In-vivo Wound Closure Rate (compared to predicate/control) | "The report findings showed that the rate of wound closure in receipt of Silver Antimicrobial Wound Gel showed no significant differences when compared to the Hydrogel and 'Wet to Dry' gauze treatment." |
| In-vivo Wound Adherence (compared to predicate/control) | "Wound site adherence...was not detected for the Silver Antimicrobial Wound Gel or Hydrogel at any point in the study" (significant in "Wet to Dry" gauze treated wounds). This indicates better performance than "Wet to Dry" gauze. |
| In-vivo Peri-wound Inflammation/Erythema | "Peri-wound inflammation/erythema was less frequently observed and less severe in Silver Antimicrobial Wound Gel and Hydrogel treated wounds than in similar control 'Wet to Dry gauze' treated wounds." This indicates better performance than "Wet to Dry" gauze. |
| In-vivo Adverse Effects | "No adverse effects were noted following the use of either of the Silver Antimicrobial Wound Gel or the Hydrogel 'dressings' investigated." |
| Substantial Equivalence to Predicate Device (K073197) | "The Silver Antimicrobial Wound Gel...is substantially equivalent to Advanced Medical Solutions Limited's Antimicrobial Wound Gel, 510(k) # K073197." This is the overarching acceptance criterion for the 510(k) submission. Demonstrated through the above testing, biocompatibility, and antimicrobial activity. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not explicitly stated in terms of number of subjects or wounds for the in-vivo porcine study. It only mentions "an in-vivo porcine study."
- Data Provenance: The in-vivo study was a porcine study (animal model). The country of origin for the data is not specified, but the applicant is based in the United Kingdom. It is a prospective study as it describes an assessment over time ("day 2 & 4 assessment points").
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not mentioned. The in-vivo study involved direct observation and measurement of wound characteristics in a porcine model, rather than expert interpretation of images or clinical data for ground truth establishment in the way an AI medical device would.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not mentioned. Adjudication methods like 2+1 or 3+1 are typically used for expert consensus in clinical image interpretation, not for direct observations in an animal model.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic aids, not for a wound care gel.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. The device is a wound care gel, not an algorithm. Therefore, "standalone" performance in the context of AI is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the in-vivo study, the "ground truth" (or outcome measures) were direct observations of wound closure rate, wound site adherence, peri-wound inflammation/erythema, presence of debris, and adverse effects in a porcine model. These are direct physical measurements and observations.
- For the in-vitro study, the ground truth was based on laboratory testing against specified microorganisms following recognized standards (USP 33 and European Pharmacopoeia Edition 6.6 section 5.1.3).
8. The sample size for the training set
- Not applicable. This is a medical device (wound gel), not a machine learning model. There is no "training set."
9. How the ground truth for the training set was established
- Not applicable. There is no "training set" for this device.
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(289 days)
SILVER ANTIMICROBIAL WOUND GEL
Silver Antimicrobial Wound Gel is indicated under the medical supervision of a healthcare professional for the management of dry to moderate exuding partial and full thickness wounds such as:
- . Pressure ulcers
- Leg ulcers .
- . Diabetic ulcers
- . Graft and donor sites
- . Post-operative surgical wounds
- . Trauma wounds (dermal lesions, trauma injuries or incisions)
- 1st and 2nd degree burns .
- Abrasions and lacerations .
Silver Antimicrobial Wound Gel is an opaque, amorphous hydrogel containing a high (>80%) water content and hydrophilic polymer chains. This formulation increases the moisture within the wound through water donation which makes the gel effective in assisting the debridement and desloughing process in dry necrotic wounds, whilst maintaining a moist wound environment for optimal wound healing.
Silver Antimicrobial Wound Gel contains an antimicrobial silver compound (silver carbonate) that is an effective barrier to bacterial penetration by inhibiting the growth of broad spectrum of microorganisms which come into contact with the gel.
Silver Antimicrobial Wound Gel is available in various sizes, and is supplied in aluminium tubes fitted with screw caps. The tubes will be packed in a cardboard dispenser box, with a product insert.
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the "Silver Antimicrobial Wound Gel":
The document does not explicitly state numerical acceptance criteria in a table format for device performance. Instead, it relies on demonstrating substantial equivalence to predicate devices and adherence to established in-vitro and in-vivo testing standards.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of the submission (a 510(k) for a wound gel), the "acceptance criteria" are more implicitly derived from demonstrating safety, efficacy, and substantial equivalence to existing predicate devices.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Antimicrobial Barrier Activity (In-vitro) | Effective against Staphylococcus aureus (including MRSA), Staphylococcus epidermidis (including MRSE), Streptoccus pyogenes, Pseudomonas aeruginosa, Escherichia coli, Candida albicans, and Aspergillus niger when they come into contact with the gel. Demonstrated by 7-day log reduction and preservative efficacy test (USP 30 ). |
| Biocompatibility | Demonstrated to be in compliance with BS EN ISO 10993-1 (Biological Evaluation of Medical Devices). No adverse effects noted in the in-vivo study. |
| Wound Closure Rate (In-vivo) | No statistically significant differences in the rate of wound closure when compared to a similar hydrogel (without silver) and "Wet to Dry" gauze. |
| Wound Site Adherence (In-vivo) | Not detected for the device, similar to the comparative Hydrogel, and significantly better than "Wet to Dry" gauze. |
| Peri-wound Inflammation/Erythema (In-vivo) | Less frequently observed and less severe than in "Wet to Dry gauze" treated wounds, similar to the comparative Hydrogel. |
| No Adverse Effects (In-vivo) | No adverse effects were noted following the use of the Silver Antimicrobial Wound Gel. |
| Manufacturing Quality | Manufactured according to product specification and Good Manufacturing Practices (GMP). Risk analysis performed and controls implemented. |
| Substantial Equivalence to Predicate Devices | The indication for use, performance testing, and antimicrobial activity are substantially equivalent to "Silver Shield™ Antimicrobial Skin and Wound Gel" (K062212) and "AcryDerm Silver Antimicrobial Wound Gel" (K011994, K070333). |
2. Sample Size Used for the Test Set and Data Provenance
The document primarily references two types of testing for device performance:
-
In-vitro Testing:
- Sample Size: Not explicitly stated as a numerical count of "samples" for the antimicrobial tests. It mentions a "seven day log reduction evaluation test and preservative efficacy test in accordance with the requirements of USP 30 (Antimicrobial Effectiveness Testing)." This implies standardized methodology with defined replicates, but not a specific "sample size" in terms of clinical cases.
- Data Provenance: Not specified, but generally, in-vitro tests are conducted in laboratory settings, likely within the UK or a qualified testing facility.
-
In-vivo Testing (Porcine Study):
- Sample Size: Not explicitly stated as a number of animals or wounds. The wording describes "an in-vivo porcine study" that assessed dressing performance and compared three treatment arms (Silver Antimicrobial Wound Gel, equivalent Hydrogel without silver, and "Wet to Dry" gauze). We cannot determine the exact sample size from the provided text.
- Data Provenance: The study was "in-vivo," using porcine subjects, implying a controlled animal study. The country of origin for the study is not mentioned. It is a prospective study as it involved applying the treatments and then assessing outcomes.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- In-vitro Testing: Not applicable in the context of "experts establishing ground truth." The ground truth for antimicrobial efficacy is derived from standardized laboratory tests with defined protocols (e.g., USP 30 requirements).
- In-vivo Testing (Porcine Study): Not explicitly stated. For animal studies, assessments would typically be performed by trained researchers or veterinary professionals. It does not mention a panel of "experts" in the context of radiologists or similar clinical specialties for establishing ground truth, as this is an animal study evaluating wound healing parameters.
4. Adjudication Method for the Test Set
- In-vitro Testing: Not applicable. Results are quantitative measurements from lab tests.
- In-vivo Testing (Porcine Study): Not specified. The document states "The report findings showed that..." suggesting data collection and analysis, but no explicit adjudication method (like 2+1 or 3+1 consensus) among multiple assessors for qualitative observations is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This type of study typically involves multiple human readers evaluating medical images or cases with and without AI assistance to measure reader improvement. The provided document concerns a wound gel and its performance, not an AI-based diagnostic or assistive device for human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No, a standalone study in the context of an algorithm's performance was not conducted. The device is a wound gel, which is a physical product, not a software algorithm. Its performance is intrinsic to its physical and chemical properties and how it interacts with wounds, not through an algorithm operating independently.
7. Type of Ground Truth Used
- In-vitro Testing: Ground truth is established by standardized laboratory test results (e.g., log reduction of microbial counts for antimicrobial efficacy, compliance with ISO standards for biocompatibility).
- In-vivo Testing (Porcine Study): Ground truth is based on direct observation and measurement of wound healing parameters in a controlled animal model. This includes wound closure rate, wound site adherence, peri-wound inflammation/erythema, and general absence of adverse effects.
8. Sample Size for the Training Set
Not applicable. This device is a wound care product, not an AI or machine learning algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
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(62 days)
ELTA SILVER ANTIMICROBIAL WOUND GEL DRESSING, WOUND AND BURN, HYDROGEL W/DRUG AND/OR BIOLOGIC
Elta Silver Antimicrobial Wound Gel is indicated for the management of minor burns, superficial cuts, lacerations, abrasion and minor irritation of the skin. Under the supervision of a healthcare professional, it is indicated for partial and full thickness wounds including pressure ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns, abrasions, lacerations, skin tears, grafted wounds, donor sites and surgical wounds.
Not Found
This document is a letter from the FDA regarding the 510(k) premarket notification for the "Elta Silver Antimicrobial Wound Gel". It states that the device is substantially equivalent to legally marketed predicate devices.
The information you are asking for, regarding acceptance criteria, performance studies, sample sizes, expert qualifications, ground truth establishment, and comparative effectiveness studies, is typically found in the premarket notification submission itself, which is a much more detailed document than this FDA clearance letter. This letter is simply the FDA's decision based on their review of that submission.
Therefore, this document does not contain the information requested in your prompt. It does not describe acceptance criteria, device performance, details of studies, sample sizes, or ground truth methodologies. It only states that the device has been found substantially equivalent for the indicated uses.
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